Vascular occlusion devices utilizing thin film nitinol foils

ABSTRACT

A deployable occlusion device for filling an aneurysm. The occlusion device includes a support structure, for example a wire or otherwise elongate structure. The occlusion device also includes a mesh component having a porosity. The mesh component has a first end portion and a second end portion. The first end portion of the mesh component is attached to the support structure and the second end portion of the mesh component is a free end. The mesh component extends from the support structure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/965,919 filed Jul. 29, 2020, which is a U.S. National Phase ofInternational Application No. PCT/US2019/015716, filed Jan. 29, 2019,which claims priority benefit under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application Ser. No. 62/624,672, filed Jan. 31, 2018,titled VASCULAR OCCLUSION DEVICES UTILIZING THIN FILM NITINOL FOILS, allof which applications are hereby incorporated by reference in theirentirety.

BACKGROUND Field

This application is related to the methods and devices for treatingneurovascular aneurysms.

Description of the Related Art

The worldwide occurrence of stroke is estimated to be in the vicinity of60,000,000 instances per year. The economic and social costs for strokesare enormous. While most strokes are fatal or debilitating, even mildstrokes often result in impairment that greatly diminishes quality oflife and independence while substantially increasing direct costs forhealthcare and daily living. Further, indirect costs such as lostproductivity, expanded burden on care provided by immediate family, andthe allocation of limited resources to rehabilitative therapy andconvalescence aggregate to create a significant unmet need for theprevention of stroke beyond the current standard of care.

While advances in medical science, standards of care, preventativeactions, and an understanding of the influences of personal lifestylehave improved in the field of stroke over time, the causes of stroke arecomplex and not fully understood in all instances. Stroke is dividedinto two categories: ischemic (loss of normal blood flow) andhemorrhagic (bleeding through blood vessel rupture).

A brain (cerebral) aneurysm is a bulging, weak area in the wall of anartery that supplies blood to the brain. If a brain aneurysm ruptures (asubarachnoid hemorrhage), it releases blood into the skull resulting instroke. Depending on the severity of the hemorrhage, brain damage ordeath may result.

The risk factors for formation of aneurysms are recognized to includegenetics, gender, age, race, elevated blood pressure, smoking, andatherosclerosis. In many cases an unruptured cerebral aneurysm may onlybe discovered during tests for another, usually unrelated, condition. Inother cases, an unruptured cerebral aneurysm will cause problems bypressing on areas in the brain. When this happens, the person may sufferfrom severe headaches, blurred vision, changes in speech, and neck pain,depending on what areas of the brain are affected and how severe theaneurysm is.

An estimated 6 million people in the United States have an unrupturedbrain aneurysm, or 1 in 50 people. The annual rate of rupture isapproximately 8-10 per 100,000 people or about 30,000 people per year inthe United States who suffer a brain aneurysm rupture. There is a brainaneurysm rupturing every 18 minutes. Ruptured brain aneurysms are fatalin about 40% of cases. Of those who survive, about 66% suffer somepermanent neurological deficit.

SUMMARY

At present there are three treatment options for people with thediagnosis of cerebral aneurysm: (1) medical (non-surgical) therapy; (2)surgical therapy or clipping; and (3) endovascular therapy or coiling.

Medical therapy is usually only an option for the treatment ofunruptured intracranial aneurysms. Strategies include smoking cessationand blood pressure control. These are the only factors that have beenshown to have a significant effect on aneurysm formation, growth, andrupture. Periodic radiographic imaging may be used to monitor the sizeand growth of an aneurysm. However, because the mechanisms of aneurysmrupture are not entirely understood, and because even aneurysms of verysmall size may rupture, monitoring cerebral aneurysms is an incompletesolution to meeting medical needs.

Surgical treatment of cerebral aneurysms has existed for more than 150years, and for more than 80 years the standard of care has included theuse of aneurysm clips which have evolved into hundreds of varieties,shapes, and sizes. The mechanical sophistication of available clips,along with the advent of the operating microscope in the 1960s have madesurgical clipping the gold standard in the treatment of both rupturedand unruptured cerebral aneurysms.

Surgical clipping remains an invasive and technically challengingprocedure whereby the brain and the blood vessels are accessed throughan opening in the skull. After the aneurysm is identified, it iscarefully separated from the surrounding brain tissue. A small metalclip is then secured to the base of the aneurysm. The choice of aparticular clip configuration is based on the size and location of ananeurysm. The clip has a spring mechanism which allows the clip to closearound either side of the aneurysm, thus occluding the aneurysm from theblood vessel. Normal blood vessel anatomy is physically restored byexcluding the aneurysm sac from the cerebral circulation.

Endovascular techniques for treating aneurysms date back to the 1970swith the introduction of proximal balloon occlusion. Guido Guglielmi anAmerican-based neuroradiologist, invented the platinum detachablemicrocoil, which was used to treat the first human being in 1991.

Endovascualrly delivered coils are soft wire spirals originally made outof platinum. These coils are deployed into an aneurysm via amicrocatheter that is inserted through the femoral artery of the leg andcarefully advanced into the brain. The microcatheter is advanced intothe aneurysm itself, and the microcoils are released in a sequentialmanner. Once the coils are released into the aneurysm, the blood flowpattern within the aneurysm is significantly reduced, leading tothrombosis (clotting) of the aneurysm. A thrombosed aneurysm resists theentry of liquid blood, providing a seal in a manner similar to a clip.

Endovascular coiling is an attractive option for treating aneurysmsbecause it does not require opening of the skull, and is generallyaccomplished in a shorter timeframe, which lessens the impact ofphysical strain on the patient. A limitation of coiling is that eventualcompression of the bolus of individual coils may occur over time andthus blood flow to the aneurysm may become reestablished. Additionally,not all aneurysms are suitable for coiling: (1) wide-necked aneurysmsrequire a support scaffolding (usually a stent) as a structural supportto prevent prolapse of the coil bolus into the blood vessel; (2)aneurysms that are located in the distal reaches of the neurovasculaturemay lie beyond the reach of current microcatheter sizing; and, (3)microcatheters filled with embolic coils are not always flexible enoughto navigate the highly tortuous and fragile anatomy of neurovascularblood vessels. As experience with coiling grows, the indications andpitfalls continue to be refined. Endovascular and coil technologycontinue to improve: endovascular adjuncts, such as intracranial stents,are now available to assist in coiling procedures; the original platinummicrocoil has been refined with ever-improving features such asbiological coating and microengineering for efficiency in deployment.

More recently, endovascular devices alternative to coils have begun toopen further options for the treatment of aneurysms. Blood flowdiversion without coils may provide a less expensive, more efficient,and more adaptive means for the treatment of aneurysms.Nickel-titanium-based (NiTi) flow diversion structures provide furtheroptions for physicians and patients. At present, laser cut hypotube orbraided wire form the structures from which flow diverters are made.Laser cut hypotubes require complex manufacturing and have limitationsin the degree of expansion deformation that they can tolerate.Alternately, braided wire forms are much less complicated tomanufacture, can tolerate substantial expansion deformation, but offervery limited control of structural porosity due to the localizedunconstrained movement allowable between wires that are not mechanicallybound together.

Therefore, a substantial need exists to increase minimally invasive andcost-effective solutions to improve intracranial access using systemsand methods to control the risk and effects of hemorrhagic strokethrough means of very small, highly capable, and reliably producibleinterventional tools and implants.

Some aspects of the present disclosure provide the means and the methodsfor treating cerebral aneurysms via catheter-based, minimally invasiveinterventional systems that place a blood flow occluding implant intothe aneurysm sac.

In some embodiments of the present disclosure the implant for treatingan aneurysm is a blood flow diverter (e.g., occluder) comprised at leastin part of thin film NiTi. The NiTi material may be in the martensitic(shape memory) state, the austenitic (superelastic) state, a mixture ofboth, or may be a multilayer of several film compositions. For example,a deployed NiTi implant of the present disclosure is in substantiallythe austenitic state in situ.

Some aspects of the present disclosure are directed toward an implantfor treating an aneurysm that is a blood flow diverter (e.g., occluder)including an acceptable biocompatible metal including, but not limitedto, biocompatible stainless steel, tantalum, tungsten, titanium, NiTi,platinum, or combinations or multilayers thereof.

Some implant embodiments may be comprised at least in part of NiTi thinfilm foils wherein the film is formed in a substantially planar form andthen subsequently shaped into a three dimensional form prior toincorporation into a catheter.

Some implant embodiments may include a portion that conforms to theopening at the neck of an aneurysm.

Some implant embodiments may include a bottom portion that diverts bloodflow away from the neck and sac of an aneurysm along with one or moreadditional portions that fill at least some of the sac volume of ananeurysm.

Some implant embodiments may be comprised at least in part of NiTi thinfilms wherein the film is formed in a partially three dimensional formand then subsequently further shaped into a final three dimensional formprior to incorporation into a catheter.

Some implant embodiments may be comprised at least in part of NiTi thinfilms wherein the film is formed in a substantially three dimensionalform prior to incorporation into a catheter.

Some embodiments may be comprised at least in part of NiTi thin filmswherein the film may include regularly repeating patterns of meshedstructures. For example, a meshed structure may be formed from smalleridentical sub elements each having a substantially uniform pore sizeand/or shape with substantially uniform spacing between pores. The subelements can be arrayed in a regular connected pattern to form a largermesh. The meshed structures may be any pattern such as shown in FIG. 1B,that optimizes the film's ability to expand from a highly compressed orwrapped state such as when loaded into a small diameter catheter to asubstantially expanded state when released from a catheter into thevasculature while minimizing the degree of localized stress and strainexperienced by elements of the mesh so as not to create localized stressconcentration points.

Some embodiments may be comprised at least in part of NiTi thin filmswherein the film may include a regularly repeating pattern of meshedstructures. The meshed structures may be any pattern porosity thatoptimizes the occlusive performance of the structure.

Some embodiments may include one or more elements of thin film NiTiattached to a support structure, such as a guide wire or guide coil,that is utilized to interface with the catheter insertion mechanism forloading and release of the device and also to position the thin filmelements in the aneurysm.

Some embodiments may include one or more elements of thin film TiNiattached to a support structure, such as a guide wire or guide coil, andmay also include other laser cut hypotube or braided wire elementsattached either before or after shaping to provide added structuralsupport.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the embodiments. Furthermore, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure.

FIG. 1A shows a thin film component of an implant in a planar state.

FIG. 1B shows a partial, enlarged view of the implant shown in FIG. 1A.

FIG. 1C shows an implant as contained in a curved catheter section.

FIG. 2A shows an implant with the thin film component of FIG. 1Aattached to a support structure.

FIG. 2B shows the implant of FIG. 2A deployed in an aneurysm.

FIG. 2C shows an end view of the thin film component of FIG. 1A wrappedfor loading into a catheter assembly.

FIG. 3A shows another embodiment of a thin film component of an implantin a planar state.

FIG. 3B shows the thin film component of FIG. 3A wrapped for catheterloading.

FIGS. 4A shows an implant with the thin film component of FIG. 4Aattached to a support structure.

FIG. 4B shows the implant of FIG. 4A deployed in an aneurysm.

FIG. 5 shows another implant with the thin film component of FIG. 4Awith a support structure having a coiled configuration.

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the embodiments. Furthermore, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure.

DETAILED DESCRIPTION

As has been previously explained herein, there remains a need forfurther advancement in minimally invasive interventional treatment ofcerebral aneurysms. The tortuous anatomy, small vessel diameter, anduniquely delicate anatomy of the neurovasculature provides for aparticularly challenging set of constraints in which an interventionalsystem must operate. There is little room for error given that even thesmallest unintended consequences of an error often result in significantnegative consequences for a patient.

Access to more distally located targets becomes limited by the size andstiffness of catheter working end which in turn may be limited by thephysical aspects of the implant contained therein. A solution to thisproblem of limitation is to provide an implant structure that providesthe simultaneous abilities of compressing to a very small diameter,below 0.027 inches or smaller, while remaining flexible in itscompressed state, and then being able to expand to fixate in theinterior of the aneurysm and perform safely in situ.

The present application is directed toward an implant configured to becompressed to comply with the inner diameter of the delivery system. Theimplant includes at least one thin film component that may be carried ona rigid, semi-rigid, or completely flexible spine system (also referredto herein as a support structure, guide structure, or guidewire). Theimplant includes a biocompatible material, such as NiTi wire, (Pt)platinum, (Ta) tantalum, medical grade stainless steel or any other longterm implant materials.

Blood flow diversion does not require an absolutely solid surface inorder to be effective. The ideal result is to provide a structure thatis supple enough to avoid placing harmful pressure on the inner wall ofthe aneurysm sac while occluding blood flow within the sac, and alsodiverting blood flow back into the healthy normal pathways of the nativevessel(s), and while having enough mechanical strength to safely fix inplace, thus enabling the human body's natural endothelization, orclotting, to clot and seal off the disproportional wall section from theprimary vessel.

For example, the thin-film component may be a fine mesh where theporosity of the mesh (e.g., open area of each pore) may range fromabout, 50 microns to about 1500 microns, for example about 100 micronsto about 1000 microns, e.g., between about 100 microns and about 200microns, between about 150 microns to about 250 microns, between about200 microns to about 300 microns, between about 250 microns to about 350microns, between about 300 microns to about 400 microns, between about350 microns to about 450 microns, between about 400 microns to about 500microns, between about 450 microns to about 550 microns, between about500 microns to about 600 microns, between about 550 microns and about650 microns, between about 600 microns and about 700 microns, betweenabout 650 microns and about 750 microns, between about 700 microns andabout 800 microns, between about 750 microns and about 850 microns,between about 800 microns and about 900 microns, between about 850microns and about 950 microns, or between about 900 microns and about1000 microns. Each of the thin film components described herein caninclude a mesh structure for blood flow diversion such that the mesh isof a substantially uniform porosity in the two-dimensional configurationand in the three-dimensional configuration.

Currently, meshes for blood flow diversion or occlusion are constructedfrom braided NiTi wire. However, a braided structure inherently allowsthe individual wires of the braid to move past one another such that theunit cells formed by individual braided strands are inconsistent(uncontrolled) in size due to deformations that naturally occur duringshaping and/or handling prior to deployment. Additionally, as layers ofwire stack up in a compressed and catheterized braided implant,stiffness develops that may lead to limitations in distal vascularaccess and/or further localized deformations of an implant's braidedunit cells. These problems may be improved by creating a mesh structurefrom a monolithic material which will maintain the designed shapes ofany sub elements and which may include any medical grade material(metal, polymer, etc.) that is suitable for meeting the competingcriteria previously described. One particular material is thin film NiTiwhich has been formed in a film-like thickness and patterned to have amesh structure therein. The thin film may further be created by usingfilm deposition and patterning processes.

Moreover, intraluminal devices such as stents require aggressiveantiplatelet therapy and are associated with higher thromboembolic (TE)complication rates. Intravascular flow disrupters (IFD) are currentlybraided-wire devices designed to achieve flow disruption at the aneurysmneck without placing material in the parent vessel and without the needof antiplatelet therapy.

Better system performance may be achieved by producing IFDs made fromNiTi thin films. As opposed to a braided structure, a thin filmstructure may be patterned such that the mesh is either symmetricallyrepetitive or otherwise preferentially patterned in an asymmetric way toprovide for example surface performance optimization for a threedimensional shape with differing characteristics for the portion of thestructure against the wall of the aneurysm sac versus the portion incontact with the parent artery, and diverting blood flow. One or more ofthese thin film features can be applied to any of the implantembodiments described herein.

The thin film components of the implant described herein can be formedfrom a continuous or monolithic sheet (e.g., thin film layer). Thecontinuous or monolithic sheet can have a substantially uniformthickness and/or substantially uniform porosity in the substantiallyplanar and three-dimensional configurations or in the compressed anduncompressed configurations. The thickness can be less than or equal to0.005 inches, less than or equal to 0.003 inches, less than or equal to0.002 inches, or less than or equal to 0.001 inches.

The thin film components of the implant can be patterned with astructural mesh that maintains substantially uniform porosity (e.g.,amount of open area in a given area) in the compressed and uncompressedconfigurations. The implant's initial configuration, which may be asubstantially flat or planar configuration, can include rounded,circular, elliptical, cone, and other polygonal segments. In any of theimplant shape variants, there may be reinforcing portions with noporosity. The reinforcing portions may extend at least partially orentirely around a perimeter of the implant. The reinforcing portion mayextend at least partially or entirely across a width or length of theimplant (e.g., similar to struts). The reinforcing portions may includea same thickness as the porous or mesh portions of the implant. Inaddition to thin film mechanical properties such as material phase andphase transition temperature, residual strain, and mesh structuralpattern, further mechanical stiffness may be derived from film thicknessfrom layering of two or more thin film layers, and from stiffeners suchas pleats or spines and the like that are formed by modifying theinitial planar configuration by bending or shaping or the like into morecomplex 3D configurations.

The thin film components of the implant can be shape set to achieve thedesignated configuration so that when released into the treatment siteit shall optimally fill the aneurysm and fill, block, or shield the necktransition (primary artery to aneurysm void from the same vessel wall)to the aneurysm space. In the three-dimensional configuration, theimplant has sufficient structural support to maintain its shape in afluid pressure environment equivalent or greater to the level of highblood pressure (e.g., 3/2 psig; similar to diastolic/systolic in mm ofHG for high blood pressure).

The complete occluder assembly may include one or more thin film meshcomponents plus one or more support structures that may be wire, coil,or laser cut material. The components may be shape set individuallyprior to integration or the assembly may also be shape set as a completeor partially complete unit.

Corrosion resistance and biocompatibility may be enhanced by placementof an inert micro layer of metallic or non-metallic material at anatomic level, or greater thickness, to ensure of a surface passivationthat is robust and can resist corrosion or leach ions into the bloodsystem. The final outer surface may have a final surface finish ofmaterial that will be inert to the body and resist corrosion by placingan atomic layer of (Ti) titanium, (Pt) Platinum, (Pd) palladium, (Ir)iridium, (Au) Gold, (Ta) tantalum, or other biocompatible metals or maybe passivated by the formation of a surface titanium oxide layer.Stainless steel thin films shall be consistent with the medical gradeISO standard requirements of 316, 316L, 316 LVM, 17/7 and any other longterm implant materials.

In some embodiments, the mesh of an implant is substantially orpredominantly in the austenitic phase so as to provide the bestsuperelasticity and load carrying strength. The greater the differencebetween body temperature and the temperature at which an implant andmesh transform into the austenitic stage, the “Af temperature”, thegreater the stiffness. However, with increased stiffness come tradeoffsin fatigue resistance. Therefore, an optimized structure of mesh offersa good combination of thermomechanical properties and mesh geometry toallow for localized distortions during deployment and release in situ,during manufacturing manipulations, and during catheterized deliverythrough tortuous vasculature. Af temperatures may range from 10 degreesCelsius to 37 degrees Celsius. The film thickness can be in a range from1 micron to 50 microns, for example from about 6 microns to about 12microns, wherein the thickness is a factor in the outward force and thecontrolled resistance to compression forces from the blood vessel.

The implants described herein can be compressed by wrapping the implantaround the support structure. For example as shown in FIG. 3B, theimplant may be compressed by wrapping one portion of the thin filmcomponent over another portion of the thin film component to form anoverall conical shape. By increasing the amount or number of turns ofoverlap, the cone can be loaded into a small diameter catheter forinsertion into the vasculature. After release from catheter, the conecan expand to a larger diameter to match the size of the targetaneurysm.

Any of the embodiments described herein may include radiopaque markerbands that can be made from tantalum, titanium or precious metal andplaced on the occluder at any specific location where an eyelet ornodule is formed by the thin film process or to a support structure,such as a straight wire or wire having a coil portion, of the completedevice. The marker may be crimped, swaged, fused or adhered to theeyelet or the frame based on the optimum location for the identificationof placement of the occluder in the body by x-ray (fluoroscopy). Themarker may also be plated onto the specific location or dip plated toensure the patency of a specific area of the Occluder is visible underfluoroscopy. Alternatively, radiopacity may be achieved by adding highbrightness metals either as a surface coating or by inclusion into amultilayer structure in such amounts that do not compromise the shapingof the material into desired 3 dimensional forms or its mechanicalrobustness as required for successful deployment.

The occluder shall be sized based on the fluoroscope sizing of theaneurysm determined by the neurovascular surgeon. The catheter assemblyshall be preloaded with the specific occluder and sterilized by means ofgamma, e-beam or ETO, without impacting the overall device capabilityfor a one-time-use and achieving the trackability to the specificlocation without any friability to the delivery system or the occluder.Once in position, confirmed by the neurovascular surgeon by fluoroscopy,the center delivery wire can be manipulated by torque and axial pushingto ensure the delivery system tip is at the neck of the aneurysm area.The release shall be completed by moving the inner delivery wiredistally, or by moving the outer sheath proximally or by both at thesame time. The occluder shall change from the configured loaded shape tothe final configured shape partially as it exits the sheathed state butwill achieve its final shape once fully released from the deliverysystem.

FIGS. 1A and 1B show an embodiment of a thin film component 100 of anocclusion device in its starting two-dimensional configuration (see FIG.1A). In some configurations, this element can be constructed fromthin-film nitinol.

The occlusion device includes a mesh structure having a porosity 120with a substantially uniform or uniform pore size (see FIG. 1B). Anysingle pore size can be within at least about 5% of a pore size of anyother pore or the mean pore size. The space between any two pores can bewithin at least about 5% of the space between any other two pores or themean spacing between pores for the entire thin film component. The sizeof the perforation holes and the dimensions of the supporting mesh arechosen to maximize the occlusive performance in the device whilemaintaining sufficient structural strength to enable handling anddeployment of the device without tearing.

In the starting 2D configuration, the thin film component 100 is in aflat, planar configuration. At rest, the thin film component 100 has asubstantially uniform or uniform thickness, for example, a thickness ofthe thin film element 100 is at least about 0.2 mils and/or less than orequal to about 2.0 mils, such as between about 0.5 mils to about 1.5mils or between about 1.0 mils to about 2.0 mils.

As shown in FIG. 1A, the thin film element 100 extends from a first endportion 102 to a second end portion 104. While the main portion 108 ofthe element is formed of an array of mesh structures, it may alsoinclude additional tabs or similar structures, for example byincorporating end tabs 106 as shown in FIG. 1A.

FIG. 1B shows a close-up of a mesh structure showing the detail of thesub elements. Any of the embodiments described herein may include thisstructure of sub elements. The porosity 120 is formed frominterconnected rings 122. The pore opening dimension is chosen tooptimize the occlusive performance of the element in situ, where theporosity of the mesh (e.g., open area of each pore) may range fromabout, 50 microns to about 1500 microns, for example about 100 micronsto about 1000 microns. In the embodiment shown, each ring 122 iscircular in shape although other shapes can be utilized including butnot limited to ovals or polygons.

The cross sectional dimensions of the solid portions the rings 122 havea width and a thickness. The width is determined by the thin filmpatterning process used to delineate the layout of the structure, whilethe film thickness is determined by the amount of material depositedduring the thin film deposition process. The width w of the solidannulus of the rings can be at least about 1 micron and/or less than orequal to about 100 microns, for example from 1 to 20 microns or 5 to 10microns. The thickness (into the page in FIG. 1B) can be at least about0.2 mils and/or less than or equal to about 2.0 mils, such as betweenabout 0.5 mils to about 1.5 mils or between about 1.0 mils to about 2.0mils.

In order to create a mesh, each individual ring 122 is connected on itsouter diameter to surrounding rings at attachment points 124 to create aclose packed array.

For successful deployment into the aneurysm, the implant as constrainedin the catheter must be capable of navigating the tortuous anatomy ofthe vasculature system without damage or irreversible distortion of thecomponents. As shown in FIGS. 1A and 1B a mesh of rings is utilized. Thering structure is flexible to distortions in any direction, since thecircular rings have no preferred axis and have uniform stiffness in alldirections. As an example, as shown in FIG. 1C, if catheter 140 needs tobe pushed through a curved region in the vasculature, the regions of thedevice that transit through the outer radius 148 of the bend must expandalong the axis of the bending, relative to their shape 142 in a straightsegment, and the regions 146 on the inner radius must contract. Sincethe catheter may have to move through multiple bends in varyingdirections to reach the deployment location, it is desired that thedevice be flexible for arbitrarily orientated stretching of the meshelements.

FIG. 2A shows an implant with a thin film component 201 attached to asupport structure 202 at attachment location 203. The thin filmcomponent 201 can extend radially outward in at least one direction fromthe support structure 202. The thin film component can include any ofthe features of thin film element 100. The support structure 202 may bea straight wire or an embolic coil. The method of attachment may beadhesive, welding, soldering, or any other means and may utilize tabs,grommets, or other features delineated in the thin film.

FIG. 2B shows an embodiment where multiple thin film component 201 havebeen shape set into 3D forms prior to attachment to the supportstructure 202. FIG. 2C shows an end view of the implant that shows anexample of how a thin film component 201 can be wrapped around a supportstructure 202 for loading into a catheter tube. When released into theaneurysm, the wrapped thin film components 201 will unfold into the 3Dshape set configuration as in FIG. 2B. In some embodiments, a fulllength of the support structure is released. In some embodiments, thelength of the support structure being released is customizable in situ.

FIG. 2B shows an embodiment of a deployed implant where multiple thinfilm components 201 have been shape set into 3D forms 262 prior toattachment to the support structure 260 where 226 is an aneurysm locatedin a y-junction formed by blood vessel segments 220, 222, and 224.

Current embolic coiling treatments are based on the ability toaccurately place enough length of coil, or multiple coils, to fill thevolume of the aneurysm to a high enough packing density that blood flowinto and out of the aneurysm is reduced to a level that thrombosis canoccur. Typical volumetric fill factors are less than 40%. Since thedetailed packing of the coil into the aneurysm is largely random innature and can vary from patient to patient, it is difficult for theneurosurgeon to determine in advance or even during the implantprocedure exactly what length of coil will be required. Not enough coillength will result in insufficient packing density, and too long alength of coil can place higher radial pressure on the walls of theaneurysm, risking rupture, or leave a portion of coil protruding intothe parent blood vessel, necessitating additional implants of stent likeelements into the vessel.

By adding additional thin film components onto a support structure, asindicated above, the occlusive surface area per unit length of thesupport structure is enhanced relative to a plain coil, reducing theoverall length required to produce thrombosis and thus simplifying theprocedure. Furthermore the thin film components can be constructed withuniform and optimally sized pore opening for enhanced clottingcharacteristics.

FIGS. 3A and 3B show another embodiment. FIG. 3A shows a disc of thinfilm material 300 in its 2D configuration that has an area of uniformporosity 302 surrounded by a reinforcing portion or solid border 304with no porosity. The disc 300 can include any features of the thin filmelement 100. For example, the disc 300 can have a slot 306 with tabs308. At the center of the disc is a hole 310 that may have additionaltabs 312. One or more thin film components 300 can be wrapped around asupport structure, such as a guide wire or coil, as shown in FIG. 3B.The guide wire is inserted through the center hole 310 and may beattached in position using tabs 312 or any of the other attachmentmethods of attachment as described above with respect to FIG. 2A . Theslot 306 enables the disc 300 to be wrapped as shown in FIG. 3B withoverlapping portions and into a diameter consistent with catheterloading with minimal folding of the film. After release, the disc 300can at least partially expand to fill the aneurysm, for example as shownin FIG. 4B.

FIGS. 4A and 4B show how the thin film discs 300 are integrated into animplant assembly 400. One or more thin film discs 404 can be attached toa support structure 402 using any of the methods described above. Thethin film discs 404 can include any of the features of thin film element100 or thin film discs 300. The thin film discs 404 are of diameterslightly larger than the diameter of the aneurysm so that when releasedfrom the catheter they will unwind to achieve a fit of their outer edgesto the wall of the aneurysm. Each of the thin film discs 404 form aconical configuration. One or more discs 404, for example two, three, ormore, are attached so that an apex of each cone is oriented toward adistal end of the support structure 402 and away from the aneurysm neck(see FIG. 4B) to facilitate insertion into the aneurysm. At least oneadditional disc 408 with a larger diameter than the discs 404 can beattached at the proximal end of the support structure 402 and isorientated with the apex of its cone in the opposite direction to thesmaller discs 404 and toward the proximal end of the support structure402. When disc 408 exits the catheter, it will open up to a largerdiameter than the neck of the aneurysm effectively diverting blood flowat the neck. This is shown in FIG. 4B where 430 is an aneurysm locatedin a y-junction formed by blood vessel segments 420, 422, and 424.Implant assembly 400 is shown as inserted into the aneurysm with disc408 blocking the neck.

In addition to the thin film discs, guide wire 402 may also have x-rayobservable clips 414 or similar elements attached to one or both endsand may also have attached balls 412 for detachment from the catheterpush rod.

FIG. 5 shows an additional embodiment of the assembly of type 400 thatincludes one or more thin film discs 404 and a spiral shaped portion 510that has been shape set into the guide wire 402. This region can bepulled straight prior to insertion into the catheter to provideadditional length inside the constraint of the catheter to reduce anyoverlapping between discs 404 and 408 to facilitate opening up of thecones during the implanting process. It also functions to provide apulling force to seat disc 408 onto the opening neck of the aneurysm.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements, and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements, and/or steps are inany way required for one or more embodiments.

The terms “comprising,” “including,” “having,” and the like aresynonymous and are used inclusively, in an open-ended fashion, and donot exclude additional elements, features, acts, operations, and soforth. Also, the term “or” is used in its inclusive sense (and not inits exclusive sense) so that when used, for example, to connect a listof elements, the term “or” means one, some, or all of the elements inthe list.

Although certain embodiments and examples have been described herein, itwill be understood by those skilled in the art that many aspects of thedelivery systems shown and described in the present disclosure may bedifferently combined and/or modified to form still further embodimentsor acceptable examples. All such modifications and variations areintended to be included herein within the scope of this disclosure. Awide variety of designs and approaches are possible. No feature,structure, or step disclosed herein is essential or indispensable.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. It is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment. Thus, for example, those skilled in the art willrecognize that the disclosure may be embodied or carried out in a mannerthat achieves one advantage or a group of advantages as taught hereinwithout necessarily achieving other advantages as may be taught orsuggested herein.

Moreover, while illustrative embodiments have been described herein, thescope of any and all embodiments having equivalent elements,modifications, omissions, combinations (e.g., of aspects across variousembodiments), adaptations and/or alterations as would be appreciated bythose in the art based on the present disclosure. The limitations in theclaims are to be interpreted broadly based on the language employed inthe claims and not limited to the examples described in the presentspecification or during the prosecution of the application, whichexamples are to be construed as non-exclusive. Further, the actions ofthe disclosed processes and methods may be modified in any manner,including by reordering actions and/or inserting additional actionsand/or deleting actions. It is intended, therefore, that thespecification and examples be considered as illustrative only, with atrue scope and spirit being indicated by the claims and their full scopeof equivalents.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount close to the stated amount that still performs adesired function or achieves a desired result. For example, the terms“approximately”, “about”, and “substantially” may refer to an amountthat is within less than 10% of the stated amount. As another example,in certain embodiments, the terms “generally parallel” and“substantially parallel” refer to a value, amount, or characteristicthat departs from exactly parallel by less than or equal to 15 degrees.

Example Embodiments

The following example embodiments identify some possible permutations ofcombinations of features disclosed herein, although other permutationsof combinations of features are also possible.

1. A deployable occlusion device for filling an aneurysm, the occlusiondevice comprising:

-   -   a support structure comprising a wire; and    -   a mesh component comprising a porosity, the mesh component        comprising a first end portion and a second end portion, the        first end portion being attached to the support structure and        the second end portion being a free end, the mesh component        extending radially outward from the support structure.

2. The occlusion device of Embodiment 1, wherein the mesh component isconfigured to transition between a compressed state and an uncompressedstate, the mesh component forming a coil in the uncompressed state.

3. The occlusion device of Embodiment 2, wherein in the compressedstate, the mesh componentis wrapped around the support structure.

4. The occlusion device of any one of Embodiments 1 to 3, wherein thesupport structure comprises a coiled region.

5. The occlusion device of any one of Embodiments 1 to 4, wherein thesupport structure comprises a straight region.

6. The occlusion device of any one of Embodiments 1 to 5, wherein themesh component is attached to the support structure by adhesive,welding, or soldering.

7. The occlusion device of any one of Embodiments 1 to 5, wherein themesh component is mechanically attached to the support structure.

8. The occlusion device of Embodiment 7, wherein the mesh component hasat least one tab for engaging the support structure.

9. The occlusion device of any one of Embodiments 1 to 8, wherein themesh component is monolithic.

10. The occlusion device of any one of Embodiments 1 to 9, wherein themesh component comprises a wall thickness of no more than 0.002 inches.

11. The occlusion device of any one of Embodiments 1 to 10, wherein themesh component has a substantially uniform pore size.

12. The occlusion device of any one of Embodiments 1 to 11, wherein themesh component has substantially uniform porosity.

13. The occlusion device of any one of Embodiments 1 to 12, wherein thefirst end portion does not have porosity.

14. The occlusion device of any one of Embodiments 1 to 13, furthercomprising a plurality of mesh components, each mesh component extendingfrom the support structure.

15. A deployable device for filling an aneurysm, the occlusion devicecomprising:

-   -   a support structure comprising a wire, the support structure        comprising a proximal end and a distal end; and    -   a plurality of mesh components longitudinally spaced along the        support structure, each mesh component comprising a porosity,        the mesh component being configured to transition between a        compressed state and an uncompressed state.

16. The occlusion device of Embodiment 15, wherein each mesh componentforms a conical shape in the uncompressed state so that each meshcomponent comprises an apex and an open end, the apex of each meshcomponent being attached to the support structure.

17. The occlusion device of Embodiment 15 or 16, wherein the supportstructure comprises a coiled region.

18. The occlusion device of any one of Embodiments 15 to 17, wherein thesupport structure comprises a straight region.

19. The occlusion device of any one of Embodiments 15 to 18, wherein theplurality of mesh components comprises a first mesh component and asecond mesh component.

20. The occlusion device of Embodiment 19, wherein the open end of thesecond mesh component has a larger diameter than the open end of thefirst mesh component.

21. The occlusion device of Embodiment 19 or 20, wherein the apex of thefirst mesh component is oriented in an opposite direction from the apexof the second mesh component.

22. The occlusion device of any one of Embodiments 19 to 21, wherein theapex of the second component is configured to be positioned in a neck ofthe aneurysm.

23. The occlusion device of any one of Embodiments 15 to 22, whereineach mesh component is attached to the support structure by adhesive,welding, or soldering.

24. The occlusion device of any one of Embodiments 15 to 23, whereineach mesh component is mechanically attached to the support structure.

25. The occlusion device of Embodiment 24, wherein each mesh componenthas at least one tab for engaging the support structure.

26. The occlusion device of any one of Embodiments 15 to 25, whereineach mesh component is monolithic.

27. The occlusion device of any one of Embodiments 15 to 26, whereineach mesh component comprises a wall thickness of no more than 0.002inches.

28. The occlusion device of any one of Embodiments 15 to 27, whereineach mesh component has a substantially uniform pore size.

29. The occlusion device of any one of Embodiments 15 to 28, whereineach mesh component has substantially uniform porosity.

30. The occlusion device of any one of Embodiments 15 to 29, wherein aperipheral edge of the open end of each mesh component has no porosity.

31. The occlusion device of any one of Embodiments 15 to 30, whereineach mesh component comprises a radially extending slot.

32. A method of deploying an occlusion device into an aneurysm, themethod comprising:

-   -   advancing a delivery system carrying the occlusion device to the        aneurysm;    -   deploying the occlusion device from the delivery system such        that the occlusion device transitions from a constrained        configuration to an expanded configuration, the occlusion device        comprising:        -   a support structure; and        -   a mesh structure extending from the support structure; and    -   releasing the occlusion device from the delivery system.

33. The method of Embodiment 32, wherein advancing the delivery systemcomprises advancing the delivery system through a curved region in thevasculature, the curved region having an inner radius and an outerradius, a first portion of the mesh structure expanding along an axis ofbending along the outer radius and a second portion of the meshstructure contracting along the axis of bending along the inner radius.

34. The method of Embodiment 32 or 33, wherein deploying the occlusiondevice comprising positioning a bottom portion of the occlusion deviceat a neck portion of the aneurysm and a remaining portion of theocclusion device within a sac volume of the aneurysm.

1. (canceled)
 2. An implantable occlusion device for filling ananeurysm, the occlusion device comprising: an elongate supportstructure; and a mesh component comprising arrays of rings, each ringconfigured to deform in any direction, the mesh component comprising afirst end portion and a second end portion, the first end portion beingattached to the support structure and the second end portion being afree end, the mesh component extending from the support structure. 3.The occlusion device of claim 2, wherein the mesh component isconfigured to transition between a first configuration and a secondconfiguration when deployed in the aneurysm.
 4. The occlusion device ofclaim 3, wherein in the first configuration, the mesh component iswrapped around the support structure with overlapping portions.
 5. Theocclusion device of claim 3, wherein the second configuration forms athree-dimensional configuration.
 6. The occlusion device of claim 2,wherein each ring in the mesh component is configured to connect tosurrounding rings.
 7. The occlusion device of claim 2, furthercomprising a plurality of mesh components attached to the supportstructure.
 8. The occlusion device of claim 2, wherein the supportstructure comprises a coiled wire.
 9. The occlusion device of claim 2,wherein the support structure comprises a straight wire.
 10. Theocclusion device of claim 2, wherein the mesh component is attached tothe support structure by adhesive, welding, or soldering.
 11. Theocclusion device of claim 2, wherein the mesh component is a monolithicsheet.
 12. The occlusion device of claim 2, wherein diameters of thearrays of rings are substantially the same before any deformation. 13.An implantable occlusion device for filling an aneurysm, the occlusiondevice comprising: a support structure comprising a proximal end and adistal end; and a plurality of mesh components longitudinally spacedalong the support structure, each mesh component comprising arrays ofrings, each ring configured to deform in any direction, the meshcomponent being configured to transition between a first configurationand a second configuration.
 14. The occlusion device of claim 13,wherein in the first configuration, each mesh component is wrappedaround the support structure with overlapping portions.
 15. Theocclusion device of claim 13, wherein in the second configuration, eachmesh component comprises a three-dimensional configuration that occupiesa volume.
 16. The occlusion device of claim 13, wherein each meshcomponent comprises a disc having a slot.
 17. The occlusion device ofclaim 16, wherein the disc of each mesh component has a conical shape inthe second configuration, the conical shape comprises an apex and anopen end, the apex of the disc of each mesh component being attached tothe support structure.
 18. The occlusion device of claim 13, whereineach ring in the mesh components is configured to connect to surroundingrings.
 19. A method of deploying an occlusion device into an aneurysm,the method comprising: advancing a delivery system carrying theocclusion device to the aneurysm, the occlusion device comprising asupport structure and a plurality of mesh structures extending from thesupport structure, the plurality of mesh structures wrapped around thesupport structure in a first configuration when loaded in the deliverysystem, each mesh structure having arrays of rings, each ring configuredto deform in any direction; deploying the occlusion device from thedelivery system such that the occlusion device transitions from thefirst configuration to a second configuration; and releasing theocclusion device from the delivery system.
 20. The method of claim 19,wherein advancing the delivery system comprises advancing the deliverysystem through a curved region in vasculature, the curved region havingan inner radius and an outer radius, a first portion of each meshstructure expanding along an axis of bending along the outer radius anda second portion of each mesh structure contracting along the axis ofbending along the inner radius.
 21. The method of claim 19, wherein eachring in the mesh structures is configured to connect to surroundingrings.